The drug, carbadox, is made by Teaneck, N.J.-based Phibro Animal Health and is used to control swine dysentery and bacterial enteritis, the agency said. It has also been used to promote weight gain in pigs.

“Potential cancer risks are based on an assumed lifetime of consuming pork liver or other pork products containing carbadox residues,” the agency said in a statement, adding that it is not recommending that people change their food choices while it works to remove the drug from the market.

“Pork is a good source of protein,” the agency said. “However, protein can also be found in other meat, poultry, seafood, beans and peas, eggs, processed soy products, nuts and seeds.”

Pork liver is used to make liverwurst, hot dogs, lunch meat and some types of sausage, the agency said.

Officials for Phibro, which generates annual sales of more than US$650 million and employs more than 1,100 people worldwide, according to its website, were not immediately available for comment.

Dave Warner, a spokesman for the Pork Producers Council, which represents the pork industry, said it is reviewing the implications of the FDA move but will let the Animal Health Institute, which represents animal health drug companies, “take the lead.”

A spokesman for the Animal Health Institute was not immediately available for comment.

The FDA said it asked Phibro for additional information about the safety of carbadox but the company has not submitted any proof that there is a safe way to use it.

Three antibiotics made by Phibro contain the drug: Mecadox Premix 10, Banminth/Mecadox; and Mecadox/Terramycin, the FDA said. Carbadox was approved in 1972.

Phibro has 30 days to request a hearing on the matter. If it does so, the FDA’s commissioner, Dr. Robert Califf, will decide whether a hearing is justified. If the company does not request a hearing, the agency can withdraw approvals for carbadox and it would no longer be legal in the U.S.

The FDA’s actions follow a preliminary risk assessment conducted from 2012 to 2014 which found that the lifetime cancer risk from consuming pork liver containing carbadox residue is higher than allowed under the FDA’s framework for regulating carcinogenic animal drugs.

Canada’s Veterinary Drugs Directorate in 2004 called a halt to sales of carbadox in Canada and its manufacturers withdrew their Canadian registrations for the drug.

Pfizer and Phibro had previously marketed carbadox in Canada under the Mecadox brand name and Ontario-based Bio Agri Mix had sold a carbadox-based feed premix.

Canada has since allowed imports of pork from U.S. hogs that may have been treated with carbadox, but has a zero tolerance for residue of the drug in meat.

— Toni Clarke reports for Reuters from Washington, D.C. Includes files from AGCanada.com Network staff.

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Under new FDA regulations, partially hydrogenated oils, which have been shown to raise “bad” LDL cholesterol, will be considered food additives that cannot be used unless authorized by the FDA.

The regulations take effect in three years, giving companies time to either reformulate products without partially hydrogenated oils or petition the FDA to permit specific uses of them.

Following the compliance period, no partially hydrogenated oils can be added to human food unless they are otherwise approved by the FDA.

The new regulations will apply to such oils added to human foods, regardless of whether they are sold in a grocery store, restaurant, bakery or elsewhere, and whether the food is domestically produced or imported, the FDA said. They do not, however, apply to naturally-occurring trans fats found in some animal products such as meat and dairy.

The food industry has begun preparing a petition seeking approval for limited use of trans fats in certain products, such as decorative sprinkles, the industry’s trade group, the Grocery Manufacturers Association, said.

The group on Tuesday declined to give details about its petition and what other products were involved, but expressed satisfaction with the FDA’s overall action and three-year compliance period.

“(The) FDA has acted in a manner that both addresses FDA’s concerns and minimizes unnecessary disruptions to commerce,” it said in a statement.

Efforts to remove almost all remaining trans fats from the food supply will be worthwhile, Michael Taylor, the FDA’s deputy commissioner for foods and veterinary medicine, said in a media conference call. “The public benefits far outstrip costs of compliance.”

Under current law, food additives cannot be used unless they have been approved in advance by the FDA or are generally recognized as safe. Such substances do not have to be approved before being used.

In 2013 the FDA made a preliminary determination that partially hydrogenated oils, the major dietary source of trans fat in processed foods, are no longer recognized as safe because they increase the risk of heart disease.

The oils are formed during food processing when hydrogen is added to vegetable oil to make it more solid. Reducing their use could prevent 20,000 heart attacks and 7,000 deaths, the agency said.

Currently, foods are allowed to be labeled as having “0” grams trans fat if they contain less than 0.5 grams of trans fat per serving.

The food industry has reduced its use of trans fats by 86 per cent since 2003, according to the grocers trade group. The reduction was spurred in part by the FDA’s requirement, in 2006, that trans fat levels be disclosed on package labels and by New York City’s move to curtail trans fats from restaurant meals.

The industry has reformulated many products using palm, sunflower, safflower and other oils. But there are some products that have relatively low levels of trans fats and cannot easily be reformulated.

Food companies are hoping to persuade the FDA that such products meet the agency’s food additive safety standards. To do that, they must prove with reasonable certainty that the products cause no harm.

— Reporting for Reuters by Toni Clarke in Washington, D.C. and Ransdell Pierson in New York; additional reporting for Reuters by Anjali Athavaley in New York.

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Partially hydrogenated oils, the primary dietary source of the fats, have been shown to raise “bad” cholesterol. Reducing the use of trans fats could prevent 20,000 heart attacks and 7,000 deaths from heart disease a year, the FDA said.

“While consumption of potentially harmful artificial trans fat has declined over the last two decades in the United States, current intake remains a significant public health concern,” FDA Commissioner Margaret Hamburg said.

Public health advocates welcomed the move.

“Artificial trans fat is a uniquely powerful promoter of heart disease, and today’s announcement will hasten its eventual disappearance from the food supply,” Michael Jacobson, executive director of the non-profit Center for Science in the Public Interest said.

The FDA’s proposal is not the first public effort to ban trans fats. New York City banned the use of trans fats in restaurants, including their use for deep-frying foods, and many restaurants and fast food chains, including McDonald’s, have eliminated their use.

Some European countries have also taken steps. Denmark, Switzerland and Iceland regulate the sale of many foods containing trans fats.

Products that still contain trans fats include, among others, crackers, refrigerated dough, coffee creamers and ready-to-use frosting. Some products will be harder to reformulate than others, FDA officials said.

“We know that technically this is not an insoluble problem,” Hamburg told reporters on a conference call, adding that the use of trans fats has declined dramatically since 2006, when the agency required that trans fat levels be disclosed on package labels.

According to the Grocery Manufacturers Association, food manufacturers have voluntarily lowered the amounts of trans fats in their food products by more than 73 per cent. The FDA said the average daily intake of trans fats by Americans fell from 4.6 grams a day in 2003 to one gram in 2012.

Hydrogenation is a chemical process that converts liquid vegetable oils into solid or semi-solid fats. Partially hydrogenated oils extend the shelf life of foods, and certain types of popcorn, fish sticks, pies, donuts and pizza depend on trans fats for their taste and texture.

Coming up with alternative recipes for products that contain trans fats will largely be a matter of trial and error, industry experts say. Sunflower, canola or palm kernel oil might work in some cases but some products might have to be dropped.

“If this rule becomes final the impact to companies will include the cost of finding an alternative to trans fats,” said Justin Prochnow, a lawyer with Greenberg Traurig LLP who advises food companies on FDA-related matters.

The FDA’s proposal is subject to a 60-day public comment period in which food companies are expected to outline how long they expect it to take them to reformulate products.

If the proposal becomes final, partially hydrogenated oils would be considered food additives and would not be allowed in food unless authorized by health regulators. The ruling would not affect trans fat that occur naturally in small amounts in certain meat and dairy products.

Companies wishing to include trans fats in their products would have to meet the safety standards applied to food additives and prove with reasonable certainty that they do not cause harm.

“GRAS”

It has been more than half a century since U.S. regulations governing food additives were last revised. In that time, the number of chemicals in the food supply has risen from fewer than 2,000 to an estimated 10,000, many of which are never reviewed by the FDA because companies and their advisers have declared them to be safe.

Under loose regulations created more than 50 years ago to help companies avoid lengthy delays in getting food additives approved, the FDA created a list of products considered “generally recognized as safe” (GRAS).

Companies can either petition to get their ingredients affirmed safe by the FDA, or they can declare them safe based on their own research or that of hired consultants. The FDA has the option to challenge such declarations but has rarely done so.

The FDA’s Hamburg said in an interview on Thursday that while the GRAS system provides the current legal framework for regulating food additives, the system bears re-examining to see if it is adequate to ensure the safety of the food supply.

“We do need to be thinking about what is needed to update laws and processes,” she said.

The agency is already under pressure to ban the use of caffeine in energy drinks. Caffeine was long ago declared to be a GRAS product in cola-type drinks. Yet the agency has not challenged companies to prove the safety of caffeine in other products or other beverages.

“Caffeine is one we are looking at very seriously,” Hamburg said, adding that the agency hosted a major meeting of experts over the summer under the auspices of the independent Institute of Medicine. “It’s an ongoing process but one in which we are deeply engaged.”

In the meantime, healthcare professionals welcomed the FDA’s step towards banning trans-fats in foods.

“Banning the use of artificial trans fats is a life-saving move that can help keep the public healthy,” said Patrice Harris, a member of the board of the American Medical Association.

“Healthier options, such as extra virgin olive oil, could prevent 30,000 to 100,000 premature deaths each year.”

— Toni Clarke reports on the FDA for Reuters from Washington, D.C. Ros Krasny is Reuters’ Boston bureau chief.

Related story:
U.S. trans-fat ban could boost demand for non-soy oils, Nov. 8, 2013

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The next step, the agency said, will be to conduct an analysis into the effects of long-term exposure to low levels of arsenic in rice.

The FDA’s review comes after Consumer Reports urged the government in 2012 to limit arsenic in rice, after tests of more than 60 popular products — from Kellogg’s Rice Krispies to Gerber infant cereal — showed that most contained some level of inorganic arsenic, a known human carcinogen.

The consumer watchdog group said some varieties of brown rice – including brands sold by Whole Foods Markets and Wal-Mart — contained particularly significant levels of inorganic arsenic.

In response to the report, Urvashi Rangan, Consumer Reports’ director of consumer safety and sustainability, said the FDA’s interest in the subject was “great news” and that the agency’s findings mirror its own findings.

“It doesn’t mean consumers need to throw out all the rice in their cabinets, but they should be aware that the problem is important,” she said.

The FDA said on Friday the samples it tested came from various types of rice grains, including white, jasmine and basmati. The also included samples from rice products including infant cereals, pasta, grain-based bars, cookies, pastries and drinks such as beer, rice wine and rice water.

“Taken together, the samples cover most types of rice grain and rice-based foods and beverages consumed in the United States,” the agency said.

The average levels of inorganic arsenic — the most toxic kind — ranged from 2.6 to 7.2 micrograms per serving of rice grains. Instant rice was at the low end of the range and brown rice came in at the high end.

In foods, the element may be present as inorganic arsenic or organic arsenic, the FDA said. Together they are referred to as total arsenic.

Among rice products the level of inorganic arsenic ranged from 0.1 to 6.6 micrograms per serving, with infant formula at the low end, and rice pasta at the high end. The levels are not high enough to cause any short-term health effects, the agency said.

The average amount of inorganic arsenic among 99 samples of brown rice was 7.2 micrograms, with some samples originating in the United States running as high as 10 micrograms. The average amount in instant rice was 2.6 micrograms.

Grant Lundberg, chief executive of Richvale, California-based Lundberg Family Farms, which cultivates 16,000 acres of rice, described the FDA’s findings as “old news” and said he does not expect them to have an effect on sales or consumer behavior.

“The findings the FDA is reporting are consistent with the information and samples that we’ve taken from our supply chain,” he said, “so I don’t think there’s anything in here that’s out of our expectation.”

The FDA declined to name specific products among the samples it tested, saying that while the total number of samples was large enough to accurately measure average levels of arsenic, it was not large enough to evaluate specific brands.

Some companies source their rice from different locations, which may result in samples from the same brand having different levels of arsenic over time, the agency said.

Margaret Karagas, a professor at the Geisel School of Medicine at Dartmouth in Hanover, N.H., is co-author of a study on arsenic in rice. While she applauds the FDA for undertaking such large-scale testing, she said more is needed to understand the types of arsenic found, and its geographic distribution.

Results from the FDA’s tests showed that arsenic levels in U.S.-grown rice are often higher than those in rice grown elsewhere in the world.

“We now have tools that provide greater specificity about the different types of arsenic present in foods,” the FDA said.

The agency will conduct a risk assessment to consider how much arsenic is consumed from rice products and whether there are variations in health effects for certain segments of the population.

Once complete, the assessment will help the agency determine whether further action is necessary, the FDA said. It is also conducting additional sampling to broaden its data on infant and toddler products.

In the meantime, the FDA recommends that consumers eat a well-balanced diet to minimize the potential negative effects of eating too much of any one food. It said wheat, barley and oats are among the nutritious grains that consumers can eat to vary their diet.

— Toni Clarke and Atossa Araxia Abrahamian report for Reuters from Washington, D.C. and New York City respectively.

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Members of the House Committee on Energy and Commerce wrote to Smithfield on July 24 asking the company to turn over information on its production of crude heparin, the raw ingredient used to make the drug.

As well as being the world’s largest pork producer, with more than 46,000 employees in 25 U.S. states and four countries, Smithfield is also a major supplier of crude heparin.

In a letter to Smithfield’s chief executive Larry Pope, six Republican committee members said the proposed acquisition of Smithfield by Shuanghui International Holdings “raises questions related to the safety and adequacy of the U.S. heparin supply.”

A spokeswoman for Smithfield, Keira Lombardo, confirmed the company had received the committee’s letter “and will respond within the timeframe the committee has outlined.”

The request comes just weeks after the Senate Agriculture Committee met to examine the potential food safety implications of the deal, which would be the biggest Chinese takeover of a U.S. company.

Smithfield said on Wednesday that the U.S. government has decided to take an additional 45 days to review the planned deal. Smithfield and Shuanghui submitted their proposal in June to the Committee on Foreign Investment in the United States, or CFIUS, an executive branch panel that examines foreign investment for potential threats to national security.

Many deals are approved during an initial 30-day review, but some transactions are given a second 45-day examination.

“The Committee’s investigation indicates that the U.S. heparin supply is stressed, and could well be in shortage,” the lawmakers’ letter said.

“China’s heparin market is experiencing its own pressures, and Smithfield Foods under Shuanghui control may be pressured to export its crude heparin product to China instead of supplying U.S. companies.”

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